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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePIPELINE EMBOLIZATION DEVICE
Generic NameIntracranial aneurysm flow diverter
ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
PMA NumberP100018
Supplement NumberS052
Date Received11/20/2025
Decision Date02/20/2026
Product Code OUT 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of claims regarding reduced material thrombogenicity of a proprietary surface modification for the Pipeline™ Flex Embolization Device with Shield Technology™ and Pipeline™ Vantage Embolization Device with Shield Technology™ supported by acute benchtop in-vitro testing.
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